NCT00661167已完成2 期
Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 10
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed gastric adenocarcinoma
- •Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence
- •Age: 20 - 74
- •At least one measurable lesion by RECIST criteria
排除标准
- •History of Taxans use
- •Patients with another active malignancy
- •Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE)
- •Chronic treatment with steroids
研究组 & 干预措施
1
Experimental
ABI-007
干预措施: ABI-007 (Drug)
结局指标
主要结局
Overall response rate
时间窗: During chemotherapy
次要结局
- Safety(During chemotherapy)
- Progression-free survival(Until progression)
- Overall survival(Over a year form randomaization)
- Disease control rate(Duration chemoterapy)
研究者
研究点 (10)
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